BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN

    MDR report key: 2805472 · Received September 22, 2008

    Report

    Report Number
    3003900188-2008-00043
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT CASE IS ONE OUT OF 9 INCIDENT REPORTS IN CONNECTION WITH 7B LIV IGNITIONS. EVALUATION SUMMARY: ROOT CAUSE ANALYSIS SUMMARY - THE CAUSE OF IGNITION WITH HIGHEST PROBABILITY IS IGNITION OF HYDROCARBONS, LUBRICANT AND/OR DEBRIS BY ADIABATIC COMPRESSION. POTENTIAL SOURCES OF HYDROCARBONS AND LUBRICANTS; LUBRICANT (FOMBLIN) MIGRATION (LUBRICANT FROM GCE MANUFACTURING OF VALVE). LEACHING OF CONTAMINANTS (PHTHALATES) FROM O-RINGS IN VALVES (LUBRICANT IN SOLVENT) AND HYDROCARBON OIL. LEACHING OF CONTAMINANTS (PHTHALATES) FROM FILL CONNECTOR AT FILLING PLANT AT LINDE. POTENTIAL SOURCES OF DEBRIS. DEBRIS FROM MANUFACTURING PROCESS OF VALVE AT GCE. DEBRIS FROM FILLING PLANT AT LINDE. DEBRIS FROM WEAR, VALVES IN USE. THE DESIGN (FILTER AND LOCATION OF COMPONENTS IN THE HIGH PRESSURE SIDE OF VALVE) OF THE GCE LIV VALVE 5 MICRON FILTER IS LIKELY TO CAUSE MORE SENSITIVITY TO ADIABATIC COMPRESSION HEATING THAN THE GCE OXYGEN DESIGN.

    Description of Event or Problem · 1

    ON (B)(4) 2008, LINDE INITIALLY RECEIVED A REPORT CONCERNING AN INCIDENT HAPPENING ON THE SAME DAY AT A DOCTORS POST IN (B)(6). THE INCIDENT OCCURRED DURING A DEMONSTRATION OF THE USE OF A CONOXIA 2 LITER LIV CYLINDER IN AN OUTSIDE LOCATION. AFTER OPENING THE MAIN VALVE OF THE CYLINDER AND SETTING THE FLOW-REGULATOR TO 25 L/MIN A SISSING NOISE WAS HEARD FOLLOWED BY A BANG AND A FLASH. FLAMES CAME OUT OF THE VALVE PROTECTION, THE MEDIC THREW THE CYLINDER CLEAR AND THE FIRE EXTINGUISHED IMMEDIATELY. THERE WAS LIGHT SOOT FOUND ON THE PRESSURE INDICATOR, ON VALVE PROTECTION NEAR QUICK CONNECTOR AND INSIDE VALVE BEHIND THE CONNECTOR. THERE WERE NO INJURIES AS A RESULT OF THE IGNITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN NONE ECX LINDE GAS NORTH AMERICA LLC 0710204 2657674

    Patients

    Seq Age Sex Outcome Treatment
    1